Stem Cell Infusion in the Treatment of Patients With Neurological

Status Completed

Clinical Trial Summary

This trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived MSCs (UC-MSCs) in combination with standard neurological complications after ischemic stroke treatment in Vietnam.

Clinical Trial Description

Stroke is the second leading cause of death behind ischemic heart disease worldwide. Traditional treatments have some limitations whereas preclinical data suggest that stem cell therapy is a promising regenerative medical treatment given the limited capacity of the central nervous system for self-repairs after ischemic stroke. Previous studies have shown that umbilical cord blood-derived Mesenchymal stem cell (UC-MSC) infusion improves the outcomes of several neurological damage conditions, including stroke. These results encouraged us to initiate the phase I/II clinical trial aiming to evaluate the safety and the efficiency of UC-MSC transplantation in the treatment of patients with neurological complications after ischemic stroke. This case-control phase I/II trial is conducted at Vinmec Times City International Hospital, Hanoi, Vietnam between 2021 and 2023. In this trial, 48 patients with neurological complications after ischemic stroke will be enrolled into 3 groups: UC-MSC infusion via intravenous route group (16), UC-MSC infusion via intrathecal administration route group (16), and control group (16). The UC-MSC group (IV/intrathecal) will receive two doses of thawed UC-MSC product at 1.5x106 cells/kg patient body weight with an intervention interval of three months. The primary outcome measures will include the incidence of prespecified administration-associated adverse events (AEs) and serious adverse events (SAEs). The potential efficacy will be measured using these scales including National Institutes of Health Stroke Scale-NIHSS, Functional Independence Measure -FIM, Modified Ashworth Scale-MAS, Fine motor skills-FMS, 36-Item Short Form Survey -SF-36. The clinical evaluation will be conducted at baseline and 3-, 6- and 12-months post-intervention. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05292625
Study type	Interventional
Source	Vinmec Research Institute of Stem Cell and Gene Technology
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	July 7, 2020
Completion date	November 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05196659` - Collaborative Quality Improvement (C-QIP) Study	N/A
Recruiting	`NCT06027788` - CTSN Embolic Protection Trial	N/A
Completed	`NCT03281590` - Stroke and Cerebrovascular Diseases Registry
Recruiting	`NCT05518305` - Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis
Recruiting	`NCT06029959` - Stroke and CPAP Outcome Study 3	N/A
Recruiting	`NCT03728738` - Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke	Phase 3
Terminated	`NCT03396419` - IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
Recruiting	`NCT05065216` - Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)	Phase 2/Phase 3
Recruiting	`NCT04897334` - Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke	N/A
Not yet recruiting	`NCT06462599` - Osteopontin Gene Polymorphism in Stroke Patients in Egypt
Not yet recruiting	`NCT06026696` - Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
Not yet recruiting	`NCT06032819` - Differentiating Between Brain Hemorrhage and Contrast
Recruiting	`NCT02910180` - Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
Completed	`NCT03554642` - Walkbot Robotic Training for Improvement in Gait	Phase 3
Completed	`NCT02922452` - A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects	Phase 1
Withdrawn	`NCT01866189` - Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke	N/A
Recruiting	`NCT03041753` - Reperfusion Injury After Stroke Study	N/A
Completed	`NCT02549846` - AdminiStration of Statin On Acute Ischemic stRoke patienT Trial	Phase 4
Completed	`NCT02610803` - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke	N/A
Completed	`NCT01678534` - Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Stem Cell Infusion in the Treatment of Patients With Neurological Complications After Ischemic Stroke

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms